Three-year Data on Acufocus Corneal Inlay

Staff
2/9/2012

From Paracelsus Medical University, in Salzburg, Austria, comes a report of the three-year postoperative safety and efficacy outcomes of the Acufocus corneal inlay (Acufocus, Inc.). The results support the safety and efficacy of the corneal inlay to correct presbyopia in naturally emmetropic presbyopic patients. However, despite a significant gain in uncorrected near and intermediate vision, 28.3 percent of patients lost one line of corrected distance vision.

The prospective, nonrandomized, noncomparative cohort study included 32 patients. The corneal inlay was implanted in the nondominant eye of naturally emmetropic presbyopic patients. The researchers reported refraction; uncorrected near, intermediate and distance visual acuities; corrected distance VA; contrast sensitivity; visual fields; subjective patient satisfaction and symptoms; and operative and postoperative adverse events and complications.

The mean uncorrected near VA improved from J6 preoperatively to J1 at three years and the mean uncorrected intermediate VA, from 20/40 to 20/25. At three years, 97 percent of eyes had a UNVA of J3 or better and 91 percent had a UIVA of 20/32 or better. The mean uncorrected distance VA was 20/20, with all eyes achieving 20/32 or better. Nine eyes (28.3 percent) lost one line of corrected distance VA, one eye (3.1 percent) lost more than two lines (3.8 lines), and three eyes (9.3 percent) gained one line. No inlay was explanted, and no inflammatory reactions were observed. At three years, 15.6 percent of patients reported severe night-vision problems and 6.3 percent (versus 87.5 percent preoperatively) reported being dependent on reading glasses.

Seyeddain O, Hohensinn M, Riha W, Nix G, et al.


Repeat Endothelial Keratoplasty In Patients With Failed DLEK
Repeat endothelial keratoplasty in patients with late deep lamellar endothelial keratoplasty failure is effective in improving corneal clarity and is a viable alternative to penetrating keratoplasty, say researchers at the University of Toronto, in Canada.

The retrospective study reviewed clinical records of 10 eyes of nine patients with failed DLEK surgery who underwent repeat EK surgery. The mean age at initial DLEK surgery was 71.2 years (range: 59 to 80 years), and the duration to repeat EK was 47 months (r: 16 to 63 months). Removal of the failed DLEK donor disc was performed in seven eyes; in three eyes, repeat EK was performed without removal of the failed donor disc. The mean follow-up after repeat EK surgery was 21.7 months (r: three to 44 months). Improvements in corneal clarity and visual acuity were obtained in all eyes. Mean preoperative logMAR best-corrected visual acuity was 1.46 (20/577; r: 20/100 to counting fingers) and improved to 0.64 (20/87; r: 20/30 to 20/300) at the final follow-up (p=0.03). Four eyes had limited BCVA secondary to ocular comorbidites. No significant postoperative complications were noted after repeat EK surgeries.

Kim P, Brodbaker E, Lichtinger A Yeung S, et al.


Glaucoma, Ocular Surface Disease and Quality of Life
Ocular surface disease is more common in patients with increasing glaucoma severity and is associated with poorer glaucoma-related quality of life and higher exposure to BAK, according to a group in Sydney, Australia.

Their cross-sectional study enrolled 124 participants-patients with mild (n=48), moderate (n=34) or severe (n=19) glaucoma and 23 controls (glaucoma suspects) not receiving glaucoma treatment. Severity was stratified according to binocular visual field loss. The researchers gathered demographic information, the Ocular Surface Disease Index, and Glaucoma Quality of Life-15 questionnaire scores, number and type of glaucoma medications, daily dose of benzalkonium chloride and visual field indices.

OSDI scores and the number of patients with ocular surface disease increased with increasing glaucoma severity (p<.001 and p<.005). GQL-15 scores reflected decreased quality of life with increasing glaucoma severity (p<.001). These trends were maintained after sub-stratification for age and sex.

On univariate regression OSDI was significantly correlated with GQL-15 summary score; glaucoma severity; multiple topical glaucoma medications; worse eye mean deviation and pattern standard deviation; use of topical beta blockers; topical carbonic anhydrase inhibitors; daily dose of BAK; and glaucoma filtration surgery. On multivariate regression, GQL-15 summary score (p<.001) and a daily dose of BAK greater than three (p=.018) were predictive of OSDI score.

Skalicky SE, Goldberg I, McCluskey P.


Twelve-month Outcomes in Canaloplasty and Trab
Surgeons at the Tulane School of Medicine, in New Orleans, conducted a retrospective, nonrandomized, comparative case series that compared operative outcomes of patients with open-angle glaucoma after canaloplasty and trabeculectomy through 12 months’ follow-up. The series included 33 eyes of 33 patients who underwent canaloplasty and 46 eyes of 46 patients who underwent trabeculectomy.

The main outcome measures included: change in intraocular pressure; visual acuity; number of postoperative medications; failure based on IOP (defined as IOP >18 or <4 mmHg at one year) or a second operative procedure (any eye requiring reoperation); and complication rates at 12 months.

There were no differences in demographics, previous surgery or preoperative and postoperative visual acuity between the groups. The mean percentage reduction in IOP from preoperative values at 12 months after surgery was 32 percent (±22 percent) for the canaloplasty group compared with 43 percent (±28 percent) for the trabeculectomy group (p=0.072). The median reduction in the number of medications at 12 months follow-up was three in the trabeculectomy group and two in the canaloplasty group (p=0.064).

A higher percentage of patients treated with canaloplasty (36 percent) than trabeculectomy (20 percent) required postoperative medications, although this did not attain significance (p=0.12). Failure based on IOP was 12.1 percent (four of 33 patients) for the canaloplasty group and 4.3 percent (two of 46 patients) for the trabeculectomy group (p= 0.23). There was no difference in surgical failure rates between the canaloplasty (15 percent) and trabeculectomy (11 percent) groups (p=0.74).

Ayyala RS, Chaudhry AL, Okogbaa CB, Zurakowski D.


Iontophoresis Effective for Noninfectious Anterior Uveitis
Investigators report that a prospective, Phase I/II, multicenter, double-masked, parallel group, randomized clinical trial has shown EGP-437 (dexamethasone phosphate formulated for iontophoresis, EyeGate Pharmaceuticals) to be an effective treatment in patients with noninfectious anterior uveitis. Approximately two-thirds of the patients reached an anterior chamber cell score of zero within 28 days, after only receiving one iontophoresis treatment.

Forty of 42 randomized patients received an iontophoresis treatment in one qualifying eye and completed the study. Patients were randomized into one of four iontophoresis dose groups (1.6, 4.8, 10.0 or 14.0 mA-min), treated with EGP-437 via the EyeGate II Delivery System (EGDS), and followed until day 28.

The main outcome measures were anterior chamber cell scores at days 14 and 28; time to anterior chamber cell score of zero; proportion of patients with an anterior chamber cell score reduction from baseline of ≥0.5 at day 28; mean change from baseline in ACC score at day 28; and the systemic exposures of dexamethasone and dexamethasone phosphate after EGP-437 treatment with the EGDS.

After a single EGP-437 treatment, 19 of 40 patients (48 percent) achieved an ACC score of zero at day 14. By day 28, 24 of 40 patients (60 percent) achieved an ACC score of zero. A Kaplan-Meier analysis demonstrated that the 1.6 mA-min dose was the most effective and revealed an inverse dose response; median days to an anterior chamber cell score of zero were 11.5 days in the 1.6 mA-min group versus 31 days in the 14.0 mA-min group. Twenty-six patients (65 percent) had an ACC score reduction from baseline of ≥0.5 at day 28. The mean change in anterior chamber cell score from baseline to day 28 was -2.14 with a median of -2.0.

Throughout the study, the mean intraocular pressure remained within normal range and mean best-corrected visual acuity at 4 meters remained relatively stable. Most adverse events were mild; no serious adverse events were reported. Pharmacokinetics results showed low short-term systemic exposure to dexamethasone after iontophoresis; no nonocular systemic corticosteroid-mediated effects were observed.

Cohen AE, Assang C, Patane MA, From S, Korenfeld M; Avion Study Investigators.